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Main Issues

Innovation Agenda

  • The medical technology industry is central to the development of medical technologies that will provide the life-saving and life-enhancing treatments of the future. But the innovation ecosystem that supports medical technology is severely stressed.

Regulatory Affairs

  • FDA’s 510(k) pre-market review process for medical devices provides strong protections to American patients and promotes medical innovation. It provides FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices. The 510(k) review process provides for the thorough FDA review of a wide range of products – from syringes to imaging systems – in a timely fashion that facilitates patient access to needed medical advancements.

  • Under the “Medical Device User Fee and Modernization Act of 2002” (MDUFMA), FDA was given the authority to collect user fees from medical device sponsors for review activities. Under the legislation, FDA committed to meeting specific performance goals negotiated between industry and the agency related to medical device reviews.

  • UDI consists of a unique code identifier that includes information specific for each device model as well as production data (lot or batch number, the serial number and/or expiration date), and an FDA-created database that will include a standard set of identifying elements for each UDI.

  • Along with FDA, AdvaMed believes that product quality goes beyond compliance with the current Quality System Regulation (21 C.F.R. Part 820).  The Library of Successful Quality Practices stems from this belief, and was created by AdvaMed and its members to help medical technology quality professionals.  

Payment & Health Policy

  • The Affordable Care Act included several new Medicare payment system reforms designed to improve coordination and collaboration among physicians and other healthcare providers. AdvaMed and its team of policy experts study these changes and determine their impact on patients, future medical innovation and our member companies.

  • The Affordable Care Act included several new Medicare payment and health care delivery system reforms designed to improve coordination and collaboration among physicians and other healthcare providers.  These reforms – including the development of Accountable Care Organizations (ACOs) and bundled payments – may provide incentives for providers to use innovative products that improve quality and create efficiencies in the delivery of care. 

  • Medicare covers health care items and services, including medical devices and diagnostic tests, for almost 50 million Medicare beneficiaries. In most cases, local contractors, called Medicare Administrative Contractors (or MACs) – the entities that process and pay Medicare claims –make coverage decisions, as long as those decisions do not conflict with a national policy. In some cases, Medicare develops a National Coverage Determination (NCD) for an item or service that applies to all Medicare beneficiaries that meet certain criteria for coverage.

  • The Payment & Policy Review is a new monthly communication from AdvaMed’s Payment and Health Care Delivery Policy Department that provides a short summary of important activities, reports, letters, meetings, etc. that relate to Medicare payment, coverage and quality issues.

State MedTech Alliance

  • The State Medical Technology Alliance (SMTA) is a consortium of state and regional trade associations representing their local  medical technology companies.  SMTA’s mission is to collectively support the medical technology industry on the local, state and national levels by fostering a collaborative environment through sharing of best practices, promoting the industry, and advocating for public policies that support innovation.

21st Century Cures

  • AdvaMed supports the U.S. House Energy and Commerce Committee’s 21st Century Cures initiative, a bipartisan effort led by Chairman Fred Upton (R-Mich.) and Ranking Member Diana DeGette (D-Colo.) to help speed the development and delivery of new health care treatments and cures in America.

Value of Medical Technology

  • Medical technology companies create life changing innovation. These advanced medical devices and diagnostics allow people to live longer, healthier and more productive lives. In fact, over the past 30 years, medical advancements helped add five years to U.S. life expectancy and reduce fatalities from heart disease, stroke and breast cancer by more than half.

Tax

  • There is a broad bipartisan support to repeal the device tax which is crushing company growth, job creation and chilling medical progress.

  • There is broad bipartisan agreement that comprehensive corporate tax reform is essential to improve America’s competitiveness and rebuild our nation’s economic future.

Global & Trade

  • China presents the most significant growth market for the medical device industry today and for the foreseeable future.  AdvaMed's China initiatives increase opportunities for the industry in China while, at the same time, supporting China's long-term development goals.  Specifically, AdvaMed works with China's government and private sector to promote the value of medical technologies while advocating a fair and level playing field for all manufacturers.

  • Japan is in the midst of a two-year reimbursement cycle which will culminate in the determination of the rules it will use to adjust reimbursement prices in 2014. A key concern is Japan’s plan to adopt some form of health technology assessment (HTA) as a cost containment mechanism.

  • AdvaMed's Global Strategy and Analysis Department is seperated by country and issue. This contact list serves a directory.

  • Ranking among the 20 top healthcare markets globally, India is expected to remain one of the fastest growing medical device markets over the next five years driven by emerging policies and initiatives, patient demographics and the expectations of India's rapidly growing middle-class. In addition to opportunities, however, there remain significant challenges, and AdvaMed is committed to working with public and private sector stakeholders to help bring advanced medical technologies to Indian patients.

Legal & Compliance

  • Working with nearly 300 in-house lawyers from member companies, AdvaMed’s Committee provides legal direction and leadership to ensure a legal environment that fosters medical technology innovation.

  • AdvaMed works to facilitate ethical interactions between companies and health care professionals (HCPs) globally. Ethical interactions enhance patient access to the safe and effective use of medical technologies by ensuring appropriate training of HCPs by companies.

  • The Affordable Care Act included several new Medicare payment system reforms designed to improve coordination and collaboration among physicians and other healthcare providers. AdvaMed and its team of policy experts study these changes and determine their impact on patients, future medical innovation and our member companies.

  • AdvaMed and Eucomed have developed joint compliance guidance and tools on Distributor Relations as part of an ongoing commitment to provide ethical guidance on appropriate industry interactions. We believe clear, established compliance programs will safeguard the integrity of medical decision making and promote further public confidence in our industry. 

  • Presently, no national standard exists for Health Care Industry Representative (HCIR) Credentialing. Although all stakeholders share the common goals of patient safety and quality care, the current environment subjects HCIRs to widely varying credentialing requirements, resulting in increased costs and administrative burdens which can also impede access to technology, technical support, and educational resources. AdvaMed supports the Coalition for Best Practices in HCIR Requirements  to streamline the HCIR Credentialing process for all stakeholders, while meeting the common goals of patient safety and confidentiality.

  • We understand the pressing need to ensure access to high-quality, life-saving medical technology for patients in India, in the most affordable and efficient manner possible. To advance toward this goal, we share a commitment to and fundamental belief in operating with the highest standards of ethics and integrity. The companies listed here have Ethics and Compliance teams dedicated to communicating and enforcing clear standards of conduct for their employees and distributors. If there are gaps, concerns or observations, we welcome information via the compliance hotlines, websites, and/or contacts listed here.

  • Physician-own distributorships, or "PODs," include device companies and distributors that offer substantial equity positions to physicians, in some cases, selected because collectively they are in a position to generate a substantial amount of business for the entities through ordering (or influencing orders for) devices sold or manufactured by the company. In a March 26, 2013 Special Fraud Alert, the U.S. Department of Health and Human Services Office of Inspector General (OIG) notes that the POD business structure is inherently suspect, and cites OIG's 2006 correspondence with AdvaMed on the issue.

Code of Ethics

  • The AdvaMed Code of Ethics on Interactions with Health Care Professionals ("The AdvaMed Code" ) facilitates ethical interactions between MedTech companies and health care professionals to ensure that medical decisions are based on the best interests of the patient.

  • The Certification Program is open to AdvaMed member and non-member companies, including manufacturers and distributors of medical devices. The certification requires the signatures of both the CEO and Chief Compliance Officer (CCO), attesting that their company has adopted the AdvaMed Code and implemented an appropriately tailored effective compliance program.

  • The AdvaMed Board Ethics and Health Care Compliance Committee leads AdvaMed's ethics and health care compliance initiatives, including advocacy for federal physician payment sunshine legislation and stewardship of the AdvaMed Code of Ethics on Interactions with Health Care Professionals.

  • Any company that has certified to the AdvaMed Code of Ethics may participate in the Logo Supporters Program and display the Code of Ethics Logo on print or electronic media to represent their commitment to effective compliance programming and ethical interactions with health care providers.

  • Companies Certifying to the AdvaMed Code are listed here, along with access to their compliance department contacts. Medtech companies that have certified to the AdvaMed Code support ethical collaborations between medtech manufacturers and health care providers, which are essential to advancing new technologies that benefit patients.  It is by driving ethical collaborations that we help protect patients.

  • The AdvaMed Code of Ethics on Interactions with Health Care Professionals in China ("China Code") facilitates ethical interactions between MedTech companies and health care professionals in the People's Republic of China to help ensure that medical decisions are based on the best interests of the patient.